ART and PCPNDT-Compliance Issues
ART and PCPNDT-COMPLIANCE ISSUES
Dr Manish Y Machave.
MD DNB MNAMS FICOG LLB.
Dip. Endoscopy(Germany).
Adv Dip Gyn Endoscopy( France).
Introduction–
Assisted Reproductive Technologies with In Vitro Fertilization Clinics are at a boom. The governing regulation functional at present are the ICMR guidelines with the ART Bill and Surrogacy Bill in the pipeline.
The implementation of the PCPNDT act 1994 is an issue which remains controversial to the core.
There was a Gazetted Notification under The PCPNDT act 1994 on 9th Oct 2014; a notification which said that all ART centres have to register under PCPNDT ACT as
- Genetic counselling center
- Genetic clinic
- Genetic laboratory
In accordance with which prenatal diagnostic technique(test/ procedure) is carried out at the center For example-
PND PROCEDURE- (selection of sex)USG/embryo/tissue/fluid/man/woman
PND TEST-USG/Other tests on pregnant woman/conceptus
PND TECHNIQUES-Both of the above.
The notification also said that there was no need for any new form.
F form was to be filled-
A-for all diagnostic procedures/tests
B-for non invasive procedure/tests
C-for invasive procedures/tests 21(v)-any other
D- declaration of patient/ doctor
FORM G-form of consent(for invasive techniques).
This article is intended to clear the compliance issues pertaining to various ART procedures in accordance with The PCPNDT act, 1994.
ART and PCPNDT-COMPLIANCE ISSUES
Dr Manish Y Machave.
MD DNB MNAMS FICOG LLB.
Dip. Endoscopy(Germany).
Adv Dip Gyn Endoscopy( France).
| Procedure | Forms Yes/no | Section/rule | Records | Section/rule |
|---|---|---|---|---|
| Follicular Study | NO | – | NA | – |
| Oocyte Retrival | Yes-G | Rule10 | G/D as per the case | Rule 10,9(2) |
| Embryo Transfer | Yes | Rule10 | D/E/G | Rule 10,9(2)(3) |
| IUI SCAN | N0 | – | NA | – |
| IVF | Yes | Rule 10 | D/E/G | Rule 10,9(2)(3) |
| Surrogacy | Yes | Rule4(3),9(4),10 | F/G | Rule4(3),9(4),10 |
| ICSI | Yes | Rule 10 | E/G | Rule 9(3),10 |
| Semen Analysis | NO | – | NA | – |
| PGS | Yes | Rule10 | D/E/G | Rule 9(2),(3),10 |
| PGD | Yes | Rule 10 | D/E/G | Rule 9(2),(3),10 |
| Infertile Male Patients | NO | – | NA | – |
| Testicular Biopsy | NO | NA | – | NA |
| Body fluids | Exempted | – | – | – |
| NIPT | Yes | Rule 4(3),9(4),10(1A) | F | Rule 4(3),9(4),10(1A) |